Would you volunteer for a COVID-19 vaccine trial? 1,500 people just did.
Human-challenge trials are not without risk, but they could speed up the process.
23 April, 2020
Photo by Paul Kane/Getty Images
- 1Day Sooner recruited nearly 1,500 volunteers for a potential human-challenge trial to test for COVID-19 vaccines.
- Human-challenge trials could help expedite the process that clinical trials must endure.
- At least six COVID-19 vaccination trials are currently underway, with over 70 planned around the world.
<p>Americans are being asked to sacrifice a lot right now. Shelter at home orders are in place to help limit the number of elderly and high-risk citizens flooding into hospitals, which overwhelms the health care system. It's not that we aren't feeling the pain. Over 26 million Americans <a href="https://www.reuters.com/article/us-usa-economy/millions-of-americans-join-unemployed-ranks-as-coronavirus-ravages-economy-idUSKCN2250CS" target="_blank">have filed for unemployment</a> in a mere five weeks. There are reasons for our sacrifices, yet that doesn't make them any easier to bear. </p><p>Which leads to another question of sacrifice: Would you be willing to be infected with COVID-19 as part of an early-stage vaccination trial? For nearly 1,500 healthy, young citizens, that answer is yes. </p><p><em>Nature</em> <a href="https://www.nature.com/articles/d41586-020-01179-x" target="_blank">reports</a> that roughly that number of Americans signed up for <a href="https://1daysooner.org/" target="_blank">1Day Sooner</a>, early-stage research that could potentially speed up the vaccination process, which typically takes 12-18 months. Known as a human-challenge trial, volunteers would be infected so that researchers could test vaccines and treatments—basically, a rushed clinical trial, with everyone well-informed of the stakes.</p>
Germany approves trials of COVID-19 vaccine candidate
<span style="display:block;position:relative;padding-top:56.25%;" class="rm-shortcode" data-rm-shortcode-id="fe74512eeda9131768a527f3b522fbb2"><iframe type="lazy-iframe" data-runner-src="https://www.youtube.com/embed/Cx2nIW6wAfw?rel=0" width="100%" height="auto" frameborder="0" scrolling="no" style="position:absolute;top:0;left:0;width:100%;height:100%;"></iframe></span><p>1Day Sooner co-founder, Josh Morrison (whose organization is not funded by companies working on a coronavirus vaccine), is pre-qualifying volunteers now in case human-challenge trials are coming down the pipeline. He's hoping that this enthusiasm will help inspire politicians and public policy experts to expedite the testing process. Being a high-risk endeavor, Morrison believes the payoff could be even bigger.</p><p style="margin-left: 20px;">"Many note that they recognize the risk but believe the benefits of vaccine acceleration are so tremendous that it is worth it to them."</p><p>1Day Sooner isn't the only organization looking for a vaccine. Two volunteers <a href="https://www.bbc.com/news/health-52394485" target="_blank">were just injected</a> with COVID-19 as part of a study at Oxford—the first of over 800 people that have signed off on being tested. </p><p>Meanwhile, volunteers at Kaiser Permanente's Vaccine Treatment and Evaluation Unit in Seattle are undergoing their <a href="https://www.usatoday.com/story/news/2020/04/22/second-round-shots-first-coronavirus-vaccine-test-start/3008506001/" target="_blank">second round of vaccination trials</a>. That study began on March 16. </p><p>Hong Kong's CanSino Biologies, in partnership with the Beijing Institute of Biotechnology, has also <a href="https://fortune.com/2020/04/13/who-70-coronavirus-vaccines-human-testing/" target="_blank">just entered phase 2</a> of their clinical trials. </p><p>Clinical trials at Beth Israel are planned to launch in September, with companies such as Johnson and Johnson <a href="https://www.bostonglobe.com/2020/03/30/business/us-j-j-commit-1b-coronavirus-vaccine-co-developed-by-beth-israel/" target="_blank">dedicating $1 billion</a> to this research. </p><p>The World Health Organization announced its <a href="https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments" target="_blank">Solidarity Trial</a>, with over 100 countries participating in an effort to identify effective treatments as soon as possible. All told, the WHO announced <a href="https://fortune.com/2020/04/23/coronavirus-vaccine-update-who/" target="_blank">six coronavirus trials</a> that are currently underway, with <a href="https://fortune.com/2020/04/13/who-70-coronavirus-vaccines-human-testing/" target="_blank">over 70 planned</a> around the world. </p><img type="lazy-image" data-runner-src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMzE1OTQ5NC9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTYyMjg1ODA5OX0.7jHRaC85oKRNjxAjp4trG-LbrB2tLqfbsa40IWDV18o/img.jpg?width=1245&coordinates=0%2C35%2C0%2C71&height=700" id="37f4c" class="rm-shortcode" data-rm-shortcode-id="fd15fa815746418faaf5e6f57eef7f55" data-rm-shortcode-name="rebelmouse-image" data-width="1245" data-height="700" />
A red cross nurse applies a vaccine during a drive thru influenza vaccination operation at Riocentro on March 26, 2020 in Rio de Janeiro, Brazil. This vaccination does not prevent against the coronavirus (COVID-19), but helps the most vulnerable from other diseases.
Photo by Bruna Prado/Getty Images
<p>A human-challenge trial, such as the one being proposed by 1Day Sooner, is not without potentially deadly consequences. Nir Eyal, director at the Center for Population-Level Bioethics at Rutgers University, recently said that human-challenges are not uncommon. They've been conducted on cholera and malaria. COVID-19 is a bit different, given its novelty. While we don't know the extent of damage of this virus, overall he thinks such trials are <a href="https://www.nature.com/articles/d41586-020-00927-3" target="_blank">worth the risk</a>. </p><p style="margin-left: 20px;">"The main attraction is that they could greatly accelerate the time to approval and potential use. The thing that takes the longest time in testing vaccines is phase III efficacy testing. That's done on many, many people, some of whom get the vaccine and some of whom get placebos or competing vaccine candidates. Researchers then look for differences between these two groups in infection rates."</p><p>Making a sacrifice is always a gamble, yet it points to the importance of a <a href="https://bigthink.com/politics-current-affairs/five-lessons-from-coronavirus" target="_self">collectivist mindset</a>: It's not just about you, but everyone. These volunteers deserve a lot of respect for their service.</p><p>--</p><p><span></span><em>Stay in touch with Derek on <a href="http://www.twitter.com/derekberes" target="_blank">Twitter</a> and <a href="https://www.facebook.com/DerekBeresdotcom" target="_blank">Facebook</a>. His next book is</em> "Hero's Dose: The Case For Psychedelics in Ritual and Therapy."</p>
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Social distancing measures recommended until 2022
Two new studies shed light on the road ahead.
20 April, 2020
Photo by David Dee Delgado/Getty Images
- Harvard researchers have recommended that intermittent social distancing measures should be in place until 2022.
- An observational study in Hong Kong found that social distancing measures have helped the nation avoid stricter lockdowns.
- America has a severe testing shortage that is delaying our ability to effectively measure the impact of COVID-19.
<p>While the media spotlight over the last week has been on fringe groups protesting at state capitals, most of the American population is staying at home and respecting social distancing guidelines while outside. It's the primary reason we haven't had to endure previously forecasted numbers of emergency room cases and deaths. Health care workers on the front lines in major cities are overwhelmed as it is. Our duty is to not make their incredibly stressful jobs more demanding than they already are.</p><p>Social distancing is an important weapon for containing this virus, according to researchers at the WHO Collaborating Centre for Infectious Disease Epidemiology and Control. In a <a href="https://www.thelancet.com/journals/lanpub/article/PIIS2468-2667(20)30090-6/fulltext" target="_blank">new observational study</a> published in The Lancet, the Hong Kong-based team looked in their own backyard to see how their country was able to flatten the curve without requiring stricter stay-at-home orders. </p><p>Hong Kong, like South Korea and Singapore, <a href="https://www.vox.com/policy-and-politics/2020/3/13/21178289/confirmed-coronavirus-cases-us-countries-italy-iran-singapore-hong-kong" target="_blank">instituted preventive measures</a> immediately. These countries were testing citizens as soon as possible; they began requiring distancing and protective equipment when cases were first detected. Testing is key. As Cynthia Cox, the director of the Peterson-Kaiser Health System Tracker, <a href="https://www.vox.com/policy-and-politics/2020/3/13/21178289/confirmed-coronavirus-cases-us-countries-italy-iran-singapore-hong-kong" target="_blank">told Vox</a>,</p><p style="margin-left: 20px;">"The testing failure is putting additional strain on our already challenged health system. The combination of all of these factors will make the US worse off than similar countries."</p>
Researchers predict US may have to endure social distancing until 2022
<span style="display:block;position:relative;padding-top:56.25%;" class="rm-shortcode" data-rm-shortcode-id="174742300e508171dbe22873d958db8e"><iframe type="lazy-iframe" data-runner-src="https://www.youtube.com/embed/yy-yj3kFrV8?rel=0" width="100%" height="auto" frameborder="0" scrolling="no" style="position:absolute;top:0;left:0;width:100%;height:100%;"></iframe></span><p>WHO researchers reviewed three telephone surveys between January 20 and March 13 to understand attitudinal changes as the disease progressed. They analyzed COVID-19 cases alongside influenza data and watched the reproduction number of coronavirus cases. And they discovered that a combination of behavioral changes, such as social distancing and wearing protective gear in public, border restrictions, and isolation of confirmed cases (and their contacts) helped to slow the spread.</p><p style="margin-left: 20px;">"Our findings strongly suggest that social distancing and population behavioural changes—that have a social and economic impact that is less disruptive than total lockdown—can meaningfully control COVID-19."</p><p>The researchers warn that relaxed policies, which began in March, are likely to lead to an increase in cases. Tracing is an essential strategy if nations hope to avoid serious outbreaks. Interestingly, the team noticed that social distancing also reduced influenza transmissions, which is important given that, for vulnerable populations, hospital beds are being occupied by COVID-19 patients. </p><p>Hong Kong's example could help set a precedent for other nations. The researchers write that all of these considerations need to be in place. At the moment, there does not seem to be a singular silver bullet.</p><p style="margin-left: 20px;">"Because a variety of measures were used simultaneously, we were not able to disentangle the specific effects of each one, although this may become possible in the future if some measures are strengthened or relaxed locally, or with use of cross-national or subnational comparisons of the differential application of these measures."</p><p>Meanwhile in America, officials are <a href="https://www.msnbc.com/rachel-maddow-show/texas-dan-patrick-many-seniors-willing-sacrifice-economy-n1167521" target="_blank">calling for seniors to sacrifice their lives</a> for the economy, <a href="https://www.nytimes.com/2020/04/18/health/coronavirus-america-future.html" target="_blank">testing is woefully absent</a>, and the president's sole focus is <a href="https://www.cnn.com/2020/04/18/politics/trump-economy-coronavirus/index.html" target="_blank">getting business going again</a>, health consequences be damned. These are the exact opposite measures than those health experts are proposing. </p><img type="lazy-image" data-runner-src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yMzE0NTY4Ny9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY0MzA2MDcwMn0.TwBC1HV--9-ksohQGdpTPDasIaB0g4Z_dDKTcEHb4s4/img.jpg?width=1245&coordinates=0%2C68%2C0%2C38&height=700" id="24b9a" class="rm-shortcode" data-rm-shortcode-id="5de00d26f1a7b51ff3f5c13f70178d3d" data-rm-shortcode-name="rebelmouse-image" data-width="1245" data-height="700" />
Two men not observing social distancing playing basketball in Prahran with a sign outside the court reading that the court is closed on April 15, 2020 in Melbourne, Australia.
Photo by Asanka Ratnayake/Getty Images
<p>A <a href="https://www.hsph.harvard.edu/news/hsph-in-the-news/intermittent-social-distancing-may-be-needed-through-2022-to-manage-covid-19/" target="_blank">new modeling study</a> from the Harvard T.H. Chan School of Public Health states that while a two or three-month distancing period flattens the curve, groups susceptible to COVID-19—<a href="https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-at-higher-risk.html" target="_blank">people over 65</a> and those suffering from underlying conditions, <a href="https://www.latimes.com/science/story/2020-04-15/coronavirus-risk-higher-for-obese-people" target="_blank">as well as the obese</a>—will continue to be at risk until effective treatments and, potentially, a vaccine are produced. They're recommending that we institute social distancing policies until 2022.</p><p>Aware of a contentious response to this recommendation, they note that this isn't about politics. </p><p style="margin-left: 20px;">"The authors wrote that they're aware of the severe economic, social, and educational consequences of social distancing. They said their goal is not to advocate a particular policy but to note 'the potentially catastrophic burden on the healthcare system that is predicted if distancing is poorly effective and/or not sustained for long enough.'"</p><p>There is never a return to normal, for that supposes a societal baseline that is constant. We are moving somewhere else that will one day seem like the everyday, until it shifts again. We must take responsibility for how we transition and listen to the signal in all of this noise. For now, I only have one certainty: I'm not willing to sacrifice my parents for your portfolio.</p><p><span></span>--</p><p><em>Stay in touch with Derek on <a href="http://www.twitter.com/derekberes" target="_blank">Twitter</a> and <a href="https://www.facebook.com/DerekBeresdotcom" target="_blank">Facebook</a>. His next book is</em> "Hero's Dose: The Case For Psychedelics in Ritual and Therapy."</p>
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